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1. Which patient populations can benefit from monitoring via the Implicity platform?

The Implicity platform is designed for remote monitoring of patients with cardiac implantable electronic devices (defibrillators, pacemakers and implantable loop recorders), regardless of the manufacturer. The platform can also be used to monitor patients with heart failure.

2. How does the Implicity platform simplify remote monitoring of patients with cardiac implantable electronic devices?

The Implicity platform is a universal, cloud-based solution powered by Artificial Intelligence (AI) for remote monitoring of patients with cardiac implantable electronic devices.

• Universal Aggregation: Implicity aggregates data from all manufacturers (Abbott, Biotronik, Boston Scientific, Medtronic, Microport) into a single unified dashboard. This eliminates the need for remote monitoring teams to log into multiple manufacturer portals.
• AI Prioritization: Our patented sorting algorithm¹ analyzes raw clinical alerts and prioritizes them based on their relevance and urgency, significantly reducing the “noise” of false alerts. ILR ECG Analyzer², our false positive reclassification algorithm for Medtronic implantable loop recorders (to be extended to other brands in 2026), also correctly reclassifies up to 79% of episodes with a sensitivity of 99%³.
• Optimized Workflow: The software is designed to integrate seamlessly into your existing clinical process, enabling your team to manage more patients in less time⁴, from receiving the transmission to billing.

¹IM009 Alert Management is a Class I medical device (MDD 93/42/EEC) bearing the CE mark; see the instructions for use for more information. Covered under the conditions defined in Article L. 162-52 of the Social Security Code. ²IM007 ILR ECG Analyzer is an FDA cleared Class II medical device and CE marked Class I (under MDD) medical device, see the instructions for use for more information. ³Rosier, Arnaud, et al., A novel machine learning algorithm has the potential to reduce by 1/3 the quantity of ILR episodes needing review, European Heart Journal, Volume 42, Issue Supplement_1, October 2021. ⁴Implicity study conducted in 2023 based on data from 56 medical centers, to measure the increase in productivity of medical teams after two years of using the Implicity platform.

3. What are the clinical and organizational benefits of using Implicity AI?

Implicity AI is specifically developed to transform the clinical and organizational efficiency of your clinic:

• Reduction in mortality (-26%), hospitalizations (-2%) and length of hospital stay (-4%) associated with the use of the Implicity remote monitoring platform¹.
• Reduction in False Alerts: Our studies show a significant reduction in false positives (up to 79% on events from implantable loop recorders², for example, thanks to the ILR ECG Analyzer³ algorithm), which allows your remote monitoring team to focus on cases that actually require intervention.
• Early Detection of Heart Failure: The SignalHF algorithm⁴ (available on certain CIEDs) can detect patients at high risk of hospitalization for heart failure several weeks in advance, allowing for early and potentially life-saving intervention.
• Improved Productivity⁵: By automating data sorting and analysis, the time spent per patient is optimized, increasing your clinic’s capacity to care for more remotely monitored patients without increasing your human resources.

¹Niraj Varma, Eloi Marijon, Éric Vicaut, Serge Boveda, Alexandre Abraham, Issam Ibnouhsein, Arnaud Rosier, Pascal Defaye, Jagmeet P. Singh, Impact of a Universal Monitoring system (“Third party”) on Outcomes among ICD patients: A Nationwide Study, Heart Rhythm, 2024. ²Rosier, Arnaud, et al., A novel machine learning algorithm has the potential to reduce by 1/3 the quantity of ILR episodes needing review, European Heart Journal, Volume 42, Issue Supplement_1, October 2021. ³IM007 ILR ECG Analyzer is an FDA cleared Class II medical device and CE marked Class I (under MDD) medical device, see the instructions for use for more information. ⁴SignalHF is an FDA-cleared Class II medical device only available in the USA, see the instructions for use for more information. ⁵Implicity study conducted in 2023 based on data from 56 medical centers, to measure the increase in productivity of medical teams after two years of using the Implicity platform.

4. Is the Implicity platform compliant with health data protection regulations (HIPAA and GDPR)?

Yes, compliance and data security are fundamental pillars of Implicity. The platform is designed to meet the most stringent international standards:

• HIPAA (United States): Implicity complies with the requirements of the Health Insurance Portability and Accountability Act, ensuring the confidentiality and security of Protected Health Information (PHI).
• GDPR (Europe): The platform is fully compliant with the General Data Protection Regulation. Patient data is hosted in secure data centers, often Certified Health Data Hosts (HADS) in France.
• ISO 27001 certification: Implicity maintains ISO 27001 certification (information security management), demonstrating its commitment to secure information management.
• Health Data Hosting Certification (HDS): Implicity is HDS certified in accordance with the rules relating to the hosting of health data provided for in Article L. 1111-8 of the Public Health Code.

5. How does the implementation and support of teams work?

The implementation of Implicity is designed to be simple, gradual, and fully supported by our Customer Success team.

From the outset, a dedicated Customer Success Manager will help you configure the platform according to your needs (center organization, user profiles, technical integrations). This onboarding phase ensures a quick start that is tailored to your needs.

Your teams will then benefit from targeted training sessions tailored to each profile (doctors, paramedics, administrative staff) to ensure smooth and efficient use of the platform on a daily basis.

Throughout the entire process, the Customer Success team remains at your side to:

• answer your questions,
• support changes in your usage,
• share best practices,
• implement regular activity reviews to take stock of several key points (patients included, alerts managed, patients billed…),
• and help you take full advantage of Implicity’s features.

Responsive and expert support is also available to ensure continuity of service. The goal: to secure deployment, promote adoption by teams, and maximize the clinical and organizational value of the platform.